India’s highest court has ruled that the beta crystalline form of Imatinib Mesylate (Gleevec/Glivec) is not inventive because of features found in the known alpha crystalline form. The judgment includes a discussion of changes to patent legislation, the Indian pharmaceutical industry and compliance with TRIPs.

The decision is Novartis AG vs. Union of India & ORS. and is available (PDF) from the Supreme Court’s website.

After amendments in 2005, section 3(d) of the Patent Act read as below and the Court heard argument as to the applicability of the section to the claims at issue:

Section 3. What are not inventions.– The following are not inventions within the meaning of this Act,

…

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

The Court held the view that:

It is seen above that, in course of the Parliamentary debates, the amendment in section 3(d) was the only provision cited by the Government to allay the fears of the Opposition members concerning the abuses to which a product patent in medicines may be vulnerable. We have, therefore, no doubt that the amendment/addition made in section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.[para103]

The Court addresses the argument that there is a difference between the ‘coverage’ of the claims of a patent and the disclosure of the patent and concluded:

To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents. [para 139]

As a result, the Court concluded:

In light of the discussions made above, we firmly reject the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent. We hold and find that Imatinib Mesylate is a known substance from the Zimmermann patent itself. Not only is Imatinib Mesylate known as a substance in the Zimmermann patent, but its pharmacological properties are also known in the Zimmermann patent and in the article published in the Cancer Research journal referred to above. The consequential finding, therefore, is that Imatinib Mesylate does not qualify the test of “invention” as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970. [para 157]

The Court then considered the beta crystalline form of imatinib mesylate in view of Section 3(d) of the Patent Act and held that it unpatentable because it was a new form of a known substance and the efficacy was known. [para 161] In many jurisdictions, Novartis had obtained a patent on imatnib mesylate, not just the beta crystalline form but due to changes in Indian patent law was not able to obtain just a patent on imatnib.

The decision has received significant commentary particularly in view of India’s strong generic pharmaceutical industry as well as on the cost of Gleevic and its generic equivalents. See, for example Globe and Mail, Patently-O, NY Times, CBC and Spicy IP.

Earlier this year, Justice Snider held that Teva and Apotex were not justified in their allegations of invalidity or success in their impeachment action against Canadian patents on Gleevec (see 2013 FC 141 and 2013 FC 142) although the decisions are being appealed. The Canadian patents are directed to imatinib and its salt, imatinib mesylate not to the beta crystalline form.